BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDCARE

    MDR report key: 2469298 · Received February 15, 2012

    Report

    Report Number
    2135150-2012-00003
    Event Type
    Other
    Date Received
    February 15, 2012
    Date of Event
    January 24, 2012
    Report Date
    February 15, 2012
    Manufacturer
    MEDCARE PRODUCTS
    Product Code
    FNG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REP FROM MEDCARE WENT TO THE FACILITY TO INVESTIGATE. IT WAS DETERMINED THAT THE APPROXIMATE AGE OF THE BELT IN USE WAS 7 YRS. BASED ON THE CONDITION IT WAS IN IT SHOULD HAVE BEEN REMOVED FROM SERVICE. SLINGS AND BELTS ARE TO INSPECTED FOR WEAR AND TEAR BEFORE AND AFTER EACH USE. ALSO, IT IS HARD TO UNDERSTAND THE CLAIM THAT THE RESIDENT FELL BACKWARDS BECAUSE THE BELT CAME UNCLASPED. THE BELT IS FASTENED IN THE FRONT OF THE RESIDENT. IF THIS COMES UNCLASPED THE RESIDENT'S BACKSIDE WOULD STILL BE SUPPORTED.

    Description of Event or Problem · 1

    RESIDENT WAS BEING TRANSFERRED TO THE TOILET WITH A CARE STAND AND 2 STAFF MEMBERS. THE PLASTIC CLASP ON THE BELT CAME APART WHILE THE RESIDENT WAS IN A STANDING POSITION. ACCORDING TO THE FACILITY THE RESIDENT FELL BACKWARDS AND HIT HER HEAD ON THE FLOOR. THIS RESULTED IN A HEAD LACERATION. THE RESIDENT WAS HOSPITALIZED WHERE A MRI REVEALED INTRACRANIAL BLEED. THE RESIDENT HAS SINCE BEEN RELEASED FROM THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDCARE STAND FNG MEDCARE PRODUCTS 400002

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization